Lancet integrated test element tape dispenser

ABSTRACT

A lancet integrated test element tape includes a plurality of lancet integrated test elements. The lancet integrated test elements each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. A cartridge includes a supply compartment configured to store an unused section of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test elements. The cartridge can further include a waste compartment in which a used section of the tape is stored. An indexing mechanism moves the tape between the supply and waste compartments.

CROSS REFERENCE TO RELATED APPLICATION

This application is a divisional of application Ser. No. 11/326,422,filed Jan. 5, 2006 now U.S. Pat. No. 7,481,777, which is herebyincorporated by reference.

BACKGROUND

The present invention generally relates to bodily fluid sampling devicesand more specifically, but not exclusively, concerns a dispenser forlancet integrated test element units that is configured to minimize therisk of damage of the units prior to use.

The acquisition and testing of bodily fluids is useful for many purposesand continues to grow in importance for use in medical diagnosis andtreatment, such as for diabetes, and in other diverse applications. Inthe medical field, it is desirable for lay operators to perform testsroutinely, quickly, and reproducibly outside of a laboratory setting,with rapid results and a readout of the resulting test information.Testing can be performed on various bodily fluids, and for certainapplications, is particularly related to the testing of blood and/orinterstitial fluid. Performing home-based testing can be difficult formany patients, especially for patients with limited hand dexterity, suchas the elderly or diabetics. For example, diabetics can sometimesexperience numbness or tingling in their extremities, such as theirhands, which can make self-testing difficult because they are unable toaccurately position a test strip to collect the blood sample. Inaddition, wounds for diabetics tend to heal more slowly, and as aresult, there is a desire to make incisions less invasive.

Recently, lancet integrated test strips or elements have been developedin which a test strip is integrated with a lancet or other piercingmeans so as to form a single disposable unit. While these integratedunits have somewhat simplified the collection and testing of fluidsamples, there are still a number of issues that need to be resolvedbefore a commercial unit can be implemented. One issue concernsmaintaining the sterility of the lancet prior to use so as to minimizethe risk of infection. Another issue concerns the disposal of used unitsafter use. Once used, the integrated units become a biohazard that needto be disposed of in a safe manner. A number of different types ofsystems have been proposed for dispensing test strips, lancets, or somecombination thereof, but most of these systems have significantdrawbacks, especially when used in conjunction with integrated units.

In one typical design, individual test strips are stacked within acartridge. The test strips are usually dispensed on an individual basiseither manually or via a sliding mechanism. Since test strips aredispensed individually, automatic handling of the test strips is rathercomplicated. The sliding mechanism can jam during dispensing, which candamage the test strips. Usually, after use, the test strips have to bedisposed of manually via a separate waste container.

Individual test strips or elements have been formed and/or connectedtogether to form tapes of test strips. In one design, the tape is foldedwithin a case, and individual test elements are manually dispensed bypulling on the tape. However, in the age of smaller fluid sample sizesin which the size of test strips becomes smaller, manual feeding andhandling of the tape is not practical due to the size of the test stripsinvolved. Such manual feed designs also fail to provide for automaticfeeding of the tape and automatic disposal of used sections of the tape,which are typically needed for modern systems. To address theseconcerns, automatic feed systems like reel-to-reel cassettes have beendeveloped.

Reel-to-reel type cassettes of test strips, which are similar inconstruction to normal audio cassettes, address a number of test striphandling and storage issues found with previous test strip cartridgedesigns. However, it has been recognized that there are still a numberof significant drawbacks to reel-to-reel type cassettes, especially forelectrochemical test strips, lancet integrated test strips, and otherdisposables that contain components susceptible to damage. For example,if electrochemical test strips are tightly wound around a reel in thecassette, the electrodes within the test strip can be bent or damaged insuch a way to create a short, an open condition, or otherwise damage theelectrodes, thereby making the test strip unusable. Similarly, iftightly wound around a reel, lancets within integrated units can be bentor otherwise damaged, which in turn can cause injury to the user orotherwise prevent successful lancing of the skin. To combat thisproblem, tapes of test strips or integrated units are loosely woundaround the reels. However, the loosely wound tape makes the cassetteslarger than desired and/or reduces the number of tests available beforerequiring reloading a new cassette. Even when the tape is initiallywrapped in a loose manner, the tape can become tightly wrapped as thetape is indexed, thereby damaging the tape. In addition, reel-to-reeltype cassette designs are prone to operating in reverse, which can causethe reintroduction of used test strips into the sterilized supplycompartments.

Thus, needs remain for further contributions in this area of technology.

SUMMARY

One aspect concerns a lancet integrated test tape that includes aplurality of lancet integrated test units. The lancet integrated testunits each include a lancet configured to form an incision in tissue anda test element configured to analyze body fluid from the incision in thetissue. A cartridge includes a supply compartment configured to store anunused section of the tape. The tape is folded within the supplycompartment to limit damage to the lancet integrated test units.

Another aspect concerns a tape that includes a plurality of testelements configured to analyze body fluid. A cartridge includes a supplycompartment configured to store an unused section of the tape. Theunused section of the tape is folded within the supply compartment. Thecartridge further includes a waste compartment configured to store aused section of the tape. An indexing mechanism is configured to indexthe tape between the supply compartment and the waste compartment.

A further aspect concerns a tape that includes a plurality of testelements configured to analyze body fluid. A cartridge includes a supplycompartment configured to store an unused section of the tape. Theunused section of the tape is folded within the supply compartment. Thecartridge further includes a waste compartment configured to store aused section of the tape. The used section of the tape is folded withinthe waste compartment.

Still yet another aspect concerns a technique in which a plurality oftest elements are configured to analyze body fluid are assembled on asterility sheet. A plurality of piercing members configured to piercetissue are enclosed in the sterility sheet. Each piercing member isassociated with one of the test elements to create a tape of integratedsampling elements.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of a lancet integrated test element tapeaccording to one embodiment.

FIG. 2 is a bottom view a cartridge that houses the FIG. 1 test elementtape.

FIG. 3 is a partial, cross-sectional view of the FIG. 2 cartridge.

FIG. 4 is a front view of a meter coupled to the FIG. 2 cartridge.

FIG. 5 is a first front view showing electrodes for a lancet integratedtest element tape according to another embodiment.

FIG. 6 is a second front view of the FIG. 5 test element tape onceassembled.

FIG. 7 is a front view of a lancet integrated test element tapeaccording to a further embodiment.

FIG. 8 is a cross sectional view of a cartridge according to still yetanother embodiment.

FIG. 9 is a front view of a lancet integrated test element tapeaccording to another embodiment.

FIG. 10 is a cross sectional view of a cartridge according to still yeta further embodiment.

FIG. 11 is a front view of a test element tape according to anotherembodiment.

FIG. 12 is a front view of a lancet element tape configured for use inconjunction with the FIG. 11 test element tape.

FIG. 13 is a cross sectional view of a cartridge according to a furtherembodiment.

FIG. 14 is a front view of a test element tape according to anotherembodiment.

FIG. 15 is a front view of a lancet element tape configured for use inconjunction with the FIG. 14 test element tape.

FIG. 16 is a cross sectional view of a cartridge according to still yetanother embodiment.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates. A number of embodiments of the invention areshown in detail; although it will be apparent to those skilled in therelevant art that some features that are not relevant to the presentinvention may not be shown for the sake of clarity. It should be notedthat directional terms, such as “up”, “down”, “top” and “bottom”, areused herein solely for the convenience of the reader in order to aid inthe reader's understanding of the illustrated embodiments, and it is notthe intent that the use of these directional terms in any manner limitthe described, illustrated, and/or claimed features to a specificdirection or orientation.

As mentioned previously, there have been a number of drawbacks priorcartridge or cassette designs. For example, tapes of lancets, test stripand/or lancet integrated test element (LIT) units can be damaged iftightly wound around a supply reel of a reel-to-reel cassette or othercassette types. To address these issues as well as other concerns, a LITtape according to one embodiment is stored in a folded manner within asupply compartment. By being stored in a folded manner, the tensionapplied to the tape during indexing is typically applied to only a fewof the LIT units, which in turn reduces the chance of the LIT unitsbeing damaged. To further reduce the chance of damaging the LIT units, afeed mechanism can be used to automatically feed the tape between thesupply and waste compartments of the cartridge. The feed mechanismallows the LIT units to be positioned properly for lancing and samplecollection without the need for any user manipulation.

A LIT tape 19 according to one embodiment, among many, will be describedinitially with reference to FIG. 1. Referring to FIG. 1, the tape 19includes multiple LIT devices or units 20. For further informationregarding the individual units 20, reference is made to U.S. patentapplication Ser. No. 11/070,502, filed Mar. 2, 2005, currently pending,which is incorporated by reference in its entirety. Each unit 20includes a lancet assembly or incision forming member 22 for forming anincision in tissue, a sterility sheet 24 for maintaining the sterilityof the lancet assembly 22 as well as connecting the units 20 together,and a test strip 26 for acquiring a body fluid from the incision. In theillustrated embodiment, the incision forming member 22 will describedwith reference to a lancet. It should be recognized that the lancet 22can include other devices that puncture, cut, pierce, and/or otherwiseruptures tissue, like needles and blades, to name a few examples. Boththe lancet 22 and the test strip or element 26 in the illustratedembodiment are generally flat such that the integrated lancing teststrip 20 has an overall flat appearance. Although the common term “teststrip” has been used to aid the reader in understanding the belowdescribed embodiments, it should be noted that the test elements orother biosensors described herein should not be limited to those shapedin the form of a strip, but rather, the test elements can be shapeddifferently. By being flat, multiple units 20 can be folded in compactmanner inside a cartridge, which allows a plurality of units 20 to beused without the need to individually load and/or dispose of used units20. Furthermore, the overall flat shape allows the LIT tape 19 to bemanufactured with a continuous process in which layers of componentmaterials can be layered to form contiguous strips of units 20. Itshould nonetheless be recognized that the LIT tape 19 and/or the LITunits 20 in other embodiments can have a different overall shape.

As can be seen in FIG. 1, the lancet assembly 22 has a retainer or guidemember 28 that guides a piercing member or lancet 30 during lancing. Thelancet 30 is slidably retained within a guide slot or opening 31 that isdefined in a retainer 28. In the course of lancing, the guide slot 31guides the movement of the lancet 30 during both extension andretraction. In the illustrated embodiment, the lancet 30 and theretainer 28 are separate components that are not directly attached toone another. Nevertheless, in other embodiments, the lancet 30 and theretainer 28 can be connected to one another. For example, the lancetassembly 22 can have breakable tabs that connect the lancet 30 to theretainer 28 so that the lancet 30 is held in place during manufacturingas well as prior to lancing, thereby reducing the risk of injury. Duringlancing, the tabs are broken to allow the lancet 30 to extend from theintegrated lancing test strip 20. In another example, a spring forretracting the lancet 30 connects the retainer 28 to the lancet 30.

As shown, end stops 32 of the retainer 28 extend inwardly at a slotopening 34 of the guide slot 31 so as to limit the movement of thelancet 30, thereby retaining the lancet 30 in the guide slot 31. Thelancet 30 has a body portion 35 with one or more stop edges 36, whichare wider than the slot opening 34. When the lancet 30 is fullyextended, the stop edges 36 of the lancet 30 can contact the end stops32, and thus, limit the travel of the lancet 30. However, in otherembodiments, the firing mechanism, which is used to fire the lancet 30,limits the travel of the lancet 30. A neck portion 37 of the lancet 30,which is slightly smaller that the size of the slot opening 34, extendsfrom the body portion 35 of the lancet 30. During extension of thelancet 30, the neck 37 is received between the end stops 32 such thatthe end stops 32 can limit undesirable rotation of the lancet 30 as thetissue is punctured. Extending from the neck 37, the lancet 30 has ablade portion or tip 38 that is configured to cut tissue. In theillustrated embodiment, the lancet defines an engagement notch 39 forcoupling the lancet 30 to a firing mechanism. In one form, the lancetassembly 22 is made at least in part of medical grade stainless steel,but it should be recognized that the lancet assembly 22 can be made ofother materials, such as ceramics and/or plastics. Furthermore, it iscontemplated that the guide member 28 and the lancet 30 can be made ofdifferent materials and/or manufactured separately. In one embodiment,the guide member 28 and lancet 30 are formed by a photo-etchingtechnique in which a sheet of metal is photo-etched to form both theguide member 28 and the lancet 30, and in another embodiment, the lancetassembly 22 is manufactured via stamping. The lancet assembly 22 instill other embodiments can be manufactured through other techniques aswould occur to those skilled in the art.

With reference to FIG. 1, after the lancet assembly 22 is formed, thelancet assembly 22 can be then packaged within the sterility sheet 24.As will be appreciated from the discussion below, the lancet assembly 22can be packaged in the sterility sheet 24 before, during, or after thelancet assembly 22 is sterilized. In the illustrated embodiment, thesterility sheet 24 is a sheet of metallic foil, and in anotherembodiment, the sterility sheet 24 is made of plastic. It should berecognized that the sterility sheet 24 can be made of other types ofmaterials. During manufacturing, the sterility sheet 24 is folded intotwo flaps 40 with a crease or fold 42 in between, as is shown in FIG. 1.After folding, the lancet assemblies 22 are sandwiched between the twofolds 40 such that the crease 42 closes the slot opening 34 of the guideslot 31 in the lancet assembly 22. The flaps 40 are secured to theopposite (flat) sides of the lancet assembly 22 so that the lancet 30 issealed inside the guide slot 31 with the slot opening 34 closed by thecrease 42. In one form, an adhesive is used to secure the sterilitysheet to the guide member 28. Adhesive is applied on the guide member 28around the guide slot 31, but is not applied to the lancet 30 so thatthe lancet 30 is able to still slide within the guide slot 31. Althoughan adhesive is used in the illustrated embodiment, it should beunderstood that the sterility sheet 24 can be sealed with the guidemember 28 in other manners, such as through heat sealing. In theillustrated embodiment, the edges of the flaps 40 are not sealedtogether, but it is envisioned that in other embodiments the edges ofthe sterility sheet 24 can be sealed together so as to form a pocketthat encloses the entire lancet assembly 22. In still yet anotherembodiment, instead of folding the sterility sheet 24, two sterilitysheets 24 are joined together with the lancet assembly 22 sandwiched inbetween.

As depicted, the integrated lancing test strips 20 in one embodiment areformed in a continuous process. In the continuous process, the sterilitysheet 24 is a continuous band that is rolled off a reel and foldedaround a continuous band or belt of lancet assemblies 22 that arelikewise rolled from a reel. The lancet assemblies 22 are sealed betweenthe flaps 40 of the sterility sheet 24 and the test elements 26 areattached to the sheet 24 in the manner as described above. The sterilitysheet 24 joins adjacent LIT units 20 together to form the continuous LITtape 19. Between the individual units 20, the sterility sheet 24 hasfolds or weakened lines 43 that allow the tape 19 to be folded in afan-fold fashion for storage. The fold lines 43 can also be configuredto allow individual units 20 to be detached from one another. Thesterility sheet 24 can be weakened at the fold lines 43 in any number ofmanners as would occur to those skilled in the art. For example, thesheet 24 can be scored or thinned at the fold line 43, and it iscontemplated that the fold line 43 can be continuous or discontinuous.The fold lines 43 can be formed before the lancet assembly 22 is coveredby the sterility sheet 24 or afterwards. It is envisioned that the foldline 43 in other embodiments can be optional such that the tape 19naturally folds in a fan-fold or other fashion.

Once joined together, the lancet assembly 22 and the sterility sheet 24form a lancet package or packet 44. As mentioned before, the lancetassembly 22 can be sterilized before being enclosed in the sterilitysheet 24 or afterwards. The lancet assembly 22 can be sterilized throughany number of sterilization techniques as would occur to those skilledin the art, such as through chemical, heat, and/or radiationsterilization techniques, to name a few. It should be understood thatall or part of the lancet assembly 22 can be sterilized. For instance,only the lancet 30 and guide slot 31 can be sterilized, if so desired.In another embodiment, the lancet assembly 22 is sterilized after thelancet assembly 22 is packaged inside the lancet package 44. In oneform, a radiation sterilization technique is used once the lancet 30 isenclosed by the sterility sheet 24. With the lancet package 44,sterilization of the lancet assembly 22 can occur without exposing thetest strip 26 to the undesirable affects of lancet sterilization.Consequently, the lot specific calibration data can be generated beforethe lancet package 44 is attached to the test strip.

In the illustrated embodiment, the test strip 26 is an electro-chemicaltype test strip. In one particular form, the test strip 26 includes amodified version of any of the ACCU-CHEK® brand test strips (RocheDiagnostics GmbH), but it is envisioned that other types of testelements can be used. For example, the test strip 26 in otherembodiments can include an optical type test strip or can analyze fluidsamples in other manners. At one end, the test strip 26 in theillustrated embodiment includes a connection portion 46 with electricalcontacts 47 that transmit sample readings to a meter. Opposite theconnection portion 46, the test strip 26 has a capillary channel 48 witha capillary opening 49 that is configured to draw a body fluid samplefrom an incision formed by the lancet 30 via capillary action. As shouldbe appreciated, the test strip 26 inside the capillary channel 48includes an analysis region that includes electrodes, such as working,counter and reference electrodes, and reagents for analyzing the fluidsample. In one form, the connection portion 46 is connected to a meter,and the sample readings from the electrodes in the analysis region aretransmitted to the meter via the electrical contacts.

As briefly noted before, the sterilized lancet package 44 is attached tothe test strip 26 to form the integrated lancing test strip unit 20. Asdepicted, the lancet package 44 is attached at the end of the test strip26 proximal to the capillary opening 49 of the capillary channel 48. Inparticular, the guide slot opening 34 of the lancet assembly 22 and thecapillary opening 49 of the test strip 26 are positioned near oneanother in a side-by-side relationship so that when the lancet 30 formsthe incision, the capillary channel opening 49 is positioned in closeproximity to collect the body fluid. The test strip 26 is attached tothe exterior of the sterility sheet 24 enclosing the lancing member 22to complete the integrated test strip 20. The test strip 26 in one formis attached to the lancet package 44 through an adhesive, but it shouldbe recognized that the test strip 26 and lancet package 44 can beattached in other manners. In one form, the lancet package 44 isattached to the test strip 26 such that the end edges of both arealigned with another. However, in other embodiments the edges of thelancet package 44 and the test strip 26 can be offset from one another.For example, the edge of the lancet package 44 in the illustratedembodiment, as is demarked by crease 42, is recessed slightly from theedge of the test strip 26 at the capillary opening 49. By having thelancet package 44 recessed, fluid flow to the capillary channel opening49 is promoted. In another example, the sterility sheet 24 is positionedsuch that the crease 42 extends past the edge of the test strip 26. Withthis example, all or part of the sterility sheet 24 can be hydrophobicand/or hydrophilic so as to direct fluid flow towards the capillarychannel 48. In one particular form, the sterility sheet 24 extends fromthe test strip 26 such that the sterility sheet 24 acts like a flexiblewicking flag that draws fluid into the capillary channel 48.

To draw the body fluid towards the capillary channel opening 49 and awayfrom the lancet 30, the test strip 26 in the illustrated embodiment hasa fluid direction notch facing the lancet package 44. In order toenhance fluid flow towards the capillary channel opening 49, thesterility sheet 24 can be treated and/or made to be hydrophobic. Withthe sterility sheet 24 being hydrophobic, the sterility sheet cansqueegee or wipe body fluid from the lancet 30 as the lancet 30 retractsback inside the guide slot 31. It is thought that the wiping action ofthe sterility sheet 24 increases the amount of body fluid available forsampling as well as makes the lancet 30 cleaner for disposal purposes.As noted before, with the lancet 30 sealed in the lancet package 44, therisk of cross-contamination between the lancet 30 and the test strip 26is reduced.

In FIG. 1, the test strip 26 further defines a relief slot 51 throughwhich a blade tip of a cam arm extends when engaging the lancet 30during loading and firing. In addition, the relief slot 51 can be usedto vent air from the capillary channel 48 as fluid is collected. Thelength of the relief slot 51 generally approximates the length of thelancing stroke of the firing mechanism used to actuate the lancet 30.When the lancet package 44 is attached to the test strip 26, theengagement notch 39 on the lancet 30 is aligned with the relief slot 51in the test strip 26. As is described in greater detail in U.S. patentapplication Ser. No. 11/070,502, filed Mar. 2, 2005, which is againincorporated by reference in its entirety, the blade tip of a cam armfor the firing mechanism extends through the engagement notch 39 of thelancet 30 as well as into the relief slot 51. When doing so, the bladetip pierces the sterility sheet 24. During lancing, the cam arm via theblade extends and retracts the lancet 30 relative to the test strip 26.As the lancet 30 extends, the tip 38 of the lancet 30 pierces thesterility sheet 24 at crease 42. In one form, the sterility sheet 24 atthe crease 42 is weakened so as to aid in puncturing by the lancet 30,but in other forms, the crease 42 is not weakened. Once the lancet 30 isretracted back inside the guide slot 31, the two flaps 40 of thesterility sheet 24 can hold the lancet 30 inside through friction. Byengaging the lancet 30 in such a manner, the risk of accidentalpuncturing by the integrated lancing test strip 22 is reduced because itis more difficult to manually and/or accidentally actuate the lancet 30.It should be recognized that the lancet assembly 22 can incorporateother structures for engaging the lancet 30. For instance, theengagement notch 39 in the lancet 30 can be replaced with a protrusionor knob. It is also contemplated that the lancet can be fired throughnon-mechanical and/or non-contact techniques, which do not require thepuncturing of the sterility sheet 24. As an example, the lancet 30 inanother embodiment is magnetized and fired magnetically through a voicecoil driver or other magnetic drivers. With the lancet 30 enclosed inthe sterility sheet 24 both before and after lancing, the risk ofcontamination is reduced, and the risk of accidental injury is likewisereduced.

A cartridge or cassette 60 in which the test element tape 19 is housedin illustrated in FIGS. 2 and 3. FIG. 2 illustrates a top view of thecartridge 60, and FIG. 3 depicts a partial, cross-sectional view of thecartridge 60. As shown, the cartridge 60 includes a supply compartment62 in which unused LIT units 20 are stored and a waste compartment 64 inwhich used units 20 are stored. Of note, the LIT units 20 on the tape 19are folded in a fanfold fashion along fold lines 43 within the supplycompartment 62. As noted previously, LITs and test strips can be damagedwhen wrapped around a reel in cassettes. For example, the lancet in aLIT can be bent or the electrodes, capillary channel, and/or chemistrywithin the test strip can be damaged when tightly wrapped around a reelin a reel-to-reel type cassette. To avoid damage, the tape is typicallywrapped in a loose manner within a reel-to-reel cassette, which tends towaste space. Even when loosely wrapped, the lancet and/or test strip canbe bent or otherwise damaged. As the tape is indexed in a reel-to-reelcassette, the tape around the supply reel can tighten, which in turn candamage the components of the tape.

In contrast, the tape 19 in FIG. 3 is folded along the fold lines 43within the supply compartment, which in turn alleviates a number ofissues. When folded, the tape 19 in one form may have a crease at thefold lines 43 or may not have a crease in other forms. With the tape 19folded along the fold lines 43, the individual LIT units 20 remaingenerally flat or straight, which minimizes the risk of damage.Moreover, when the tape 19 is folded, the LIT units 20 can be tightlypacked within the supply compartment 62 without damaging the LIT units20. Further, the tape 19 can be indexed without causing significantdamage to the LIT units in the folded supply tape 19, because thepulling force for indexing is usually applied to merely a few of the LITunits 20 that are about to be used. In the illustrated embodiment, thetape 19 is folded in an alternating fanfold manner, but it should berecognized that the tape 19 can be folded in other manners. Forinstance, the tape 19 can be folded in an accordion fashion, and/or inanother embodiment, the tape 19 includes blank sections between the foldlines 43, which do not include LIT units 20.

Between the supply compartment 62 and the waste compartment 64, thecartridge 60 has a sampling portion 66 where the LIT units 20 samplebody fluid and a stabilizer arm 68 that stabilizes the connectionbetween the compartments 62, 64. The sampling portion 66 and/orstabilizer arm 68 can be optional or eliminated in other embodiments. Asdepicted, the sampling portion 66 and the stabilizer arm 68 define ameter cavity 70 in which at least a portion of the meter is received. Inone embodiment, the firing cam arm of the meter, which is configured toengage the engagement notch 39 in the lancet 30 during lancing, extendswithin the meter cavity. In the embodiment depicted, the samplingportion 66 is generally enclosed to assist in maintaining the sterilityof the cartridge 60, but the sampling portion 66 still incorporates anumber openings that are used to engage the LIT unit 20 during sampling.Referring to FIG. 2, the sampling portion 66 near the top of thecartridge 60, which faces the meter once engaged, has a contact opening72 where the contacts of the meter engage the contacts 47 on the LITunits 20. At the bottom of the cartridge 60 that contacts or faces thetissue during fluid acquisition, the sampling portion 66 of thecartridge 60 has a sample opening 74 through which the lancet 30 extendsduring lancing and the test strip 26 collects fluid during sampling.Near the sample opening 74 the cartridge and/or the meter canincorporate various surfaces (or mechanisms) constructed to expressfluid and/or direct the flow of the fluid. Facing the meter opening 70,the sampling portion 66 of the cartridge 60 has a lancet engagementcavity 76 through which the firing arm of the meter engages theengagement notch 39 in the lancet 30. It is envisioned that the samplingportion 66 can be configured in other manners or can be eliminatedaltogether. For instance, the tape 19 can be exposed to the outsideenvironment when in the sampling portion 66. In another example, thecompartments 62, 64 are not directly connected together so that the tape19 is threaded through the meter in a fashion similar to a filmprojector.

With reference to FIGS. 2 and 3, the waste compartment 64 includes atake-up reel around which the used section of the tape 19 is wrapped. Asshown, the reel defines an engagement socket 80 where the meter engagesand rotates the reel 78. As should be appreciated, the reel in otherembodiments can be engaged in other manners. With the reel 78, the units20 on the tape 19 are able to be advanced from the storage compartment62 to a sampling position, and then once used, the used LIT units 20 arestored in the waste compartment 64. Once the LIT units 20 are used, thetape 19 can be wrapped tightly around the reel 78 without the worry ofthe resulting damage. Bending of the LIT units 20 will usually damagethe units 20, thereby preventing the LIT units 20 from beingaccidentally used again. Moreover, the bend in the tape 19 reduces thechance of used tape being reinserted into the supply compartment 62,which could potentially contaminate the supply compartment 62. Tofurther reduce the risk of contamination, the cartridge 60 includes aratchet mechanism 82. As shown in FIG. 3, the ratchet mechanism 82includes a pawl 84 that engages a gear 85. The pawl 84 can be biased bya spring or other biasing devices. With such a construction, the ratchetmechanism 82 only allows the reel 78 to rotate in one direction suchthat the tape 19 is only able to travel inside the waste compartment 64.It should be recognized that other types of ratchet mechanisms can beused. The waste compartment 64 further incorporates a guide spindle 86that guides the tape 19 into the waste compartment 64. To minimize therisk of contamination, the entrances of the compartments 62, 64 includeseals 88 that seal against opposite sides of the tape 19. In selectedembodiments, the supply compartment 62 includes a desiccant to reducehumidity in the supply compartment 62.

FIG. 4 depicts a body fluid sampling system 90 in which the cartridge 60is coupled to a meter 92. The cartridge 60 can be coupled to the meter92 in any number of different manners as would occur to those skilled inthe art, such as through a snap fit connection and/or through a bayonetstyle connection. It is envisioned that in other embodiments thecartridge 60 and meter 92 can be integrated together to form a singleunit. Alternatively, the cartridge 60 and meter 92 can be completelyseparate, but can remotely communicate via a wireless connection orother remote connection. As depicted, the meter 92 includes a display 94for displaying test results and other information. The meter 92 furtherincludes one or more input buttons 96 for entering information into themeter 92 and a firing button 98 for firing the lancet 30 in the LIT unit20. The meter 92 can include any number of firing mechanisms for firingthe lancet 30 as would occur to those skilled in the art, such as aspring loaded firing mechanism, a voice coil driver and/or an electricmotor. As should be appreciated, the meter 92 in other embodiments can,alternatively or additionally, incorporate other types of input and/oroutput devices, like speakers, lights, keypads, and microphones, to namea few examples. Moreover, the meter 92 can be configured to connect toother devices, such as computers, via a wired or wireless connection.

To index the tape in the cartridge 60, the meter includes an indexingmechanism 100 that engages the socket 80 in the reel 78 of the cartridge60. In the illustrated embodiment, the indexing mechanism 100 includes arotatable knob 102 that rotates a drive shaft 104, which in turn engagesthe socket 80 in the reel 78. The user indexes the tape 19 in thecartridge 60 by manually rotating the knob 102, but in otherembodiments, a motor can be used to automatically index the tape 19. Theindexing mechanism 100 can further incorporate a ratchet type mechanismto prevent the indexing mechanism 100 from operating backwards, therebyreducing the chance of reintroducing a contaminated section of the tape19 back into the supply compartment 62 of the cartridge 60. In anotherembodiment, the indexing mechanism 100 operates in a fashion similar toa camera in which the firing button can only be actuated when the LITunit 20 is properly positioned over the sample opening 74 in thecartridge 60. After the lancet 30 is fired, the indexing mechanism 100is used to move the now used LIT unit 20 into the waste compartment 64.

Looking at FIG. 4, the meter 92 includes a contact engagement member 106that aligns with the contact opening 72 in the cartridge 60. The contactengagement member 106 has contacts 108 that engage the contacts 47 onthe LIT unit 20, when positioned over the sample opening 74 in thecartridge 60 in order to collect fluid. In one form, the contacts 108 ofthe meter 92 are leaf spring type contacts, but the contacts 108 inother embodiments can have a different shape.

To use the meter 92, the user rotates the indexing knob 102 such thatthe tape 19 in the cartridge 60 moves an unused LIT unit 20 intoposition over sample opening 74 in the cartridge 60, and once moved intoposition, the contacts 108 of the meter 92 engage the contacts 47 of theunused LIT unit 20. The tape 19 can be indexed before or after the userplaces the meter system 90 against the skin or other tissue to belanced. To minimize the risk of contamination or infection, the usertypically indexes the tape 19 after the test has been performed so thatthe used/contaminated LIT unit 20 is stored in the waste compartment 64.Once the system 90 is placed against the incision site (or in closeproximity to the site), the user presses the firing button 98, whichcauses the lancet 30 (FIG. 1) to fire into the tissue and subsequentlyretract to form an incision in the tissue. Body fluid, such as bloodand/or interstitial fluid, bleeds from the newly formed incision, andthe body fluid is drawn into the capillary opening 49 of the capillarychannel 48 via capillary action. The electronics in the meter 92 analyzethe fluid sample in the capillary channel 48. As noted before, theelectrodes in the channel 48 of the LIT unit 20 are coupled to the meter92 via contacts 47. In the illustrated embodiment, the fluid sample iselectrochemically analyzed, such as via amperometric, coulumetric,and/or potentiometric techniques, to name a few, but it should beunderstood that the fluid can be analyzed through other techniques, suchas optically. The individual units 20 and/or the cartridge 60 canincorporate machine-readable coding, like barcodes, EEPROMS, resistanceidentification and the like, for calibrating the meter 92 and/orproviding additional information. The results from the analysis aredisplayed on the display 94 of the meter 92 or outputted in some othermanner. Once the sample is analyzed, the user can index the tape 19 viathe indexing mechanism 100 so that the spent unit 20 is deposited in thewaste compartment 64. Once all or nearly all of the units 20 are used,the user can dispose of the cartridge 60 and replace the cartridge 60with a new one.

An integrated test element tape 110 according to another embodiment willnow be described with references to FIGS. 5 and 6. The illustrated testelement tape 110 shares a number of features in common with thepreviously described embodiments, and for the sake of clarity as well asbrevity, these common features will not be described in great detailbelow, but reference is made to the previous discussion. In theillustrated embodiment, the sterility sheet 24 acts as a base upon whichthe rest of test elements (strips) 111 are formed. Turning to FIG. 5,one or more electrodes 112 with contacts 47 are formed on the sterilitysheet 24. The electrodes 112 can include electrodes of the type known tothose skilled in the art, such as working, counter, and/or referenceelectrodes. It should be understood that the tape 110 can include moreor less electrodes than are shown in the drawings. Moreover, it iscontemplated that one of the electrodes 112 can be formed on thesterility sheet 24, while other electrodes 112 are formed on otherlayers of the test element 111. As can be seen, the analysis ends of theelectrodes 112 (as well as the sterility sheet 24) are covered with areagent 114 for analyzing the fluid sample. As should be appreciated,the reagent 114 includes chemicals for analyzing fluids, such asenzymes, mediators and the like, for example. It is envisioned that thereagent 114 can be applied to the sterility sheet 24 before or after theelectrodes 112 are formed on the sterility sheet 24. Moreover, in otherembodiments, the reagent 114 can be applied to other layers of the tape110.

Referring to FIG. 6, each LIT unit 116 includes a spacer member 118 thatin part defines the capillary channel 48, and a vent member 120 thatforms a vent slot 122 for venting air from the capillary channel 48. Acover layer or sheet 124 covers the capillary channel 48 in a mannersuch that the channel opening 49 is able to collect a fluid sample.Similar to the previous embodiments, the lancet 22 is enclosed in thesterility sheet 24 by folding the flaps 40 of the sheet 24 along foldline 42 and sealing the flaps 40 together. In FIG. 6, one of the LITunits 116 is shown with the tip 38 of the lancet 22 in an extended statein order to show how the tip 38 extends to puncture the sterility sheet24, but it should be understood that the tip 38 is normally retractedinside the sheet 24 prior to use. Like the previous embodiments, thetape 110 is folded along fold lines 43 for packaging the tape in thesupply compartment of a cartridge. As noted previously, the tape 110 atthe fold lines 43 in one embodiment can be scored, perforated, orotherwise structured to promote folding, but in other embodiments, thefold lines 43 can be no different from the rest of the tape 110 andmerely demark where the tape 110 is folded.

The tape 110 can by manufactured and sterilized via a number oftechniques. As should be recognized, the lancet 22 can be sterilizedutilizing any number of sterilization techniques. Moreover, the lancet22 can be sterilized before being enclosed in the sterility sheet 24, orafterwards, such as through radiation sterilization. Some sterilizationtechniques are detrimental to the chemistry of reagents. A number ofmanufacturing techniques can be used to address this issue. In oneembodiment, the lancet 22 is sterilized and enclosed within thesterility sheet 24 before the electrodes 112, the reagent 114, and othercomponents of the LIT units 116 are applied to the sterility sheet 24.This technique reduces the chance of the chemistry in the reagent 114being affected by the sterilization of the lancet 22. In anotherembodiment, some or all of components for the LIT units 116, which arenot affected by the sterilization of the lancet 22, are attached priorto sterilization of the lancet 22. For instance, in one technique, theelectrodes 112 are formed on the sterility sheet 24 before the lancet 22is sterilized and enclosed in the sterility sheet 24. With anothertechnique, the electrodes 112, spacer 118, and vent member 120 areattached to the sterility sheet 24 prior to the sterilization andenclosure of the lancet 22. After sterilization, the reagent 114 isdeposited into the capillary channel 48 on or near the electrodes 112,and the cover sheet 124 is then applied over the capillary channel 48.In still yet another embodiment, all of the components of the testelement, including the reagent 114, are assembled on the sterility sheet24. Afterwards, the lancets 22 are sterilized and packaged in thesterility sheet 24 (or vice versa). In order to compensate for theaffects of sterilization, the lot calibration readings, which are usedto calibrate a meter prior to testing, are taken after the assembledunits 116 have been sterilized.

A test element tape 126 with individual LIT units 128 according toanother embodiment will be described with reference to FIGS. 7 and 8.The tape 126 in FIG. 7 is structurally similar to and shares a number ofcomponents in common with the tape 110 illustrated in FIGS. 5 and 6, andthe tape 126 in FIG. 7 is likewise manufactured in a similar fashion tothe one illustrated in FIGS. 5 and 6. For instance, the tape includeselectrodes 112 formed on the sterility sheet 24, the reagent 114 foranalyzing the fluid sample, and the lancet 22 wrapped in the sterilitysheet 24. In the FIG. 7 embodiment, however, the individual units 128are not separate and distinct, but rather, are formed from continuouslayers of material. As shown, the tape 126 has a spacer layer 130 thatin part defines the capillary channel 48 for each LIT unit 128, and avent layer 132 that forms a vent slot 134 for venting air from thecapillary channel 48. A cover layer or sheet 136 covers the capillarychannel 48 in a manner such that the channel opening 49 is able tocollect a fluid sample via capillary action. As shown, fold lines 43 areformed on the various layers between the individual units 128. Thesterility sheet 24 further includes tractor holes 138 for a tractor feedmechanism that is used to index the tape 126. In the depictedembodiment, the tractor holes 138 are formed along one edge of the tape126, but it should be appreciated that the tractor holes 138 can belocated elsewhere, formed in other layers of the tape 126, and/orinclude multiple tractor hole rows. Moreover, it is contemplated thatthe tape 126 can be indexed in other manners. To orient and align theLIT units 128, alignment notches 140 are punched (or formed in someother manner) along the edges of the tape 126 to create alignmentmembers 142, which act like alignment pins during folding and/orunfolding of the tape 126.

A cartridge 144 in which the test element tape 126 is housed illustratedin FIG. 8. As shown, the cartridge 144 includes a supply compartment 146in which the unused section of the tape 126 is stored and a wastecompartment 148 in which the used section of the tape 126 is housed.Between the compartments 146, 148, the cartridge 144 has a samplingsection 150 where the LIT units 128 collect and analyze fluid samples.Each compartment 146, 148 has an access opening 152 that faces thesampling section 150, which is sealed by seals 88. The sampling section150 has a sample opening 74 through which the lancet 22 lances thetissue and the unit 128 draws the fluid into the sample chamber 48. Inthe illustrated embodiment, the sampling section 150 includes guides 154for guiding the tape 126 and an indexing or feed mechanism 156configured to engage the tractor holes 138 in order to index the tape126. In the depicted embodiment, the feed mechanism 156 includes atractor feed mechanism, but the feed mechanism 156 can includes othertypes of feed or indexing mechanisms. The feed mechanism 156 includes anengagement socket 80 where the meter engages and moves the feedmechanism 156. In the illustrated embodiment, the feed mechanism 156includes a tractor gear. As should be recognized, the tape 126 can beguided and indexed in other manners. For instance, instead of thecartridge 144, the meter in other embodiments can incorporate the guiderollers 154 in the feed mechanism 156. In a further example, a tractorbelt or other type of indexing structure can be used in place of thetractor gear. It is contemplated that the feed mechanism 156 canincorporate a ratchet or other similar type mechanism for preventing thefeed mechanism 156 from operating in reverse. Moreover, the feedmechanism 156 can incorporate contacts for the meter that engage thecontacts 47 on the tape 126.

In the FIG. 8 cartridge 144, the tape 126 is stored in a folded mannerin both the supply 146 and waste 148 compartments, and both of thecompartments 146, 148 are oriented in a longitudinal manner. With thetape 126 folded in both compartments 146, 148, the cartridge 144 has agenerally compact configuration. During indexing, the feed mechanism 156pulls on the tape 126 so as to unfold the tape 126 in the supplycompartment 146. In the waste compartment 148, the tape 126 is foldedalong the fold lines 43 in a manner similar to a retractable wall or afolding closet door. Along both edges of the tape 126, the wastecompartment 148 has guide channels 158 in which the alignment members142 of the tape 126 are received. As the tape 126 is advanced by thefeed mechanism 156, the guide channel 158 orients the tape 126 as thetape 126 folds. Within the sampling portion 150 of the cartridge 144,the alignment members 142 can also be used to sense the position ofand/or orient each unit 128 over the sample opening 74. In addition toor as an alternative to the alignment members 142, it is envisioned thatthe tip 38 of the lancet 22 can remain slightly extended from the tape126 so that the lancet 22 can be received in the guide channel 158 ofthe waste compartment 148 in order to align and/or guide the movement ofthe tape 126. In the depicted embodiment, the guide channel 158 isfunnel shaped, but the guide channel 158 can have a different shape inother embodiments. It is contemplated that both compartments 146, 148can have guide channels 158 in order to align the tape 126. Moreover,the compartments 146, 148 can have the guide channels 158 on a singlewall of the compartment or on two opposing walls (or even more walls).Alternatively or additionally, one or more guide channels 158 can extendthrough the sampling section 150 of the cartridge 144 in order to guidethe movement of the tape 126.

A variation of the FIG. 7 tape 126 is illustrated with tape 160 in FIG.9. As can be seen, the tape 160 in FIG. 9 shares components in commonwith and is configured generally in the same fashion as the tape 126 ofFIG. 7. Like before, the test element tape 160 in FIG. 9 includes thelancets 22, the sterility sheet 24, the capillary channels 48 withopenings 49, electrodes 112 with contacts 47, the spacer layer 130, thevent layer 132 that forms the vent slot 134, the cover layer 136, andthe tractor holes 138. For the sake of clarity and brevity, only thenotable distinctions will be discussed below. Looking at FIG. 9, thetest element tape 160 has the alignment notches 140 formed along onlyone edge of the tape 160 to form the alignment members 142. Thealignment members 142 are formed on every other unit 162, near the foldline. It is contemplated that the alignment members 142 can be formedelsewhere on the tape 160.

FIG. 10 illustrates a cartridge 164 configured to store and dispense thetape 160. In the FIG. 10 embodiment, supply 166 and waste 168compartments are oriented in a side-by-side manner to give the cartridge164 a compact, u-shaped profile. Nevertheless, the cartridges in otherembodiments can be shaped differently. For instance, the cartridges inother embodiments can have a z-shaped profile or a circular shape, toname a few examples. In the circular shaped cartridge, the supply andwaste compartment can be separated by a fixed wall or a sliding wallthat allows the size of the compartments to change as the tape is used;that is, the supply compartment shrinks and the waste compartment growsas the tape is indexed into the waste compartment. Returning to theembodiment in FIG. 10, the tape 160 is stored in a folded manner in boththe supply 166 and waste 168 compartments. The compartments 166, 168each have access openings 152 with seals 88 for minimizing the risk ofcontamination.

A sampling portion 170 extends between the supply 166 and waste 168compartments. In one form, the sampling portion 170 is integrated intothe cartridge 164, and in other forms, the sampling portion 170 isseparate from the cartridge 164 (e.g., incorporated into the meterand/or elsewhere). In the depicted embodiment, the sampling portion 170includes guides 154 for guiding the tape 160, the feed mechanism 156,and the sample opening 74 where the fluid sample is collected. Thesampling portion 170 can be open to the outside environment, partiallyopen, or fully closed to the outside environment. The tractor feedmechanism 156 indexes the tape 160 by engaging the tractor holes 138 inthe manner as previously described. It should be recognized that thetape can be indexed in other manners, and the feed mechanism 156 can belocated elsewhere, such as in one of the compartments 166, 168 or on themeter, to name just a few examples. To guide the tape 160 as the tape160 unfolds and folds, the compartments 166, 168 in the illustratedembodiment include one or more guide surfaces 172 that are configured toguide the alignment members 142 on the tape 160. As should beappreciated, the tape 160 can be unguided or guided in other manners asthe tape 160 folds and unfolds.

A tape system according to yet another embodiment will be initiallydescribed with reference to FIGS. 11 and 12. In the illustratedembodiment, the system includes a test element tape 174 (FIG. 11) and apiercing member or lancet tape 176 (FIG. 12) that are originallyseparate from one another until after sterilization so as to avoid theunwanted affects of sterilization of the lancet tape 176 on thechemistry of the test element tape 174, which can affect calibration.With the tapes 174, 176 being separate, the problem ofcross-contamination between the lancets and test elements is reduced.

Looking at FIG. 11, the test element tape 174 includes a plurality oftest elements 178 that are joined together on sheet 24 to form acontinuous strip. Like the previous embodiments, each test element 178includes electrodes 112 with contacts 47, at least one capillary channel48 with sample opening 49, and reagent 114. Like before, continuouslayers on the tape 174 form various components of the test elements 178,such as the spacer layer 130, the vent layer 132 that forms the ventslot 134, the cover layer 136, and the tractor holes 138. Between eachelement 178, the tape 174 has folds line 43 where the test element tape174 is folded.

With reference to FIG. 12, the lancet tape 176 include a plurality ofincision forming members 22 that are wrapped in sterility sheet 24. Inthe illustrated embodiment, the incision forming members 22 includelancets, but it should be understood that other types of incisionforming devices can be used. The incision forming members 22 in one formare sandwiched between folded flaps 40 of the sterility sheet 24.However, in other forms, the incision forming members 22 can be coveredin other manners. To fold the lancet tape 176, fold lines 43 are definedbetween each lancet element 182. For indexing purposes, the lancet tape176 in FIG. 12 has a series of tractor openings 138, but the lancet tape176 can be indexed in other manners, which can make the tractor openings138 optional, such as via a reel mechanism of the type illustrated inFIG. 3.

For storage purposes, the tapes 174, 176 can be folded in a wide varietyof fashions. FIG. 13 illustrates one manner in which the tapes 174, 176can be folded. Referring to FIGS. 11, 12, and 13, the test element tape174 and the lancet tape 176 are joined together at every other fold line43, as indicated by reference numeral 184, to create a LIT tape 186. Inother embodiments, the test element 174 and lancet 176 tapes can bejoined together at other intervals, like at every third or fourth foldlines 43. Moreover, such intervals between join lines 184 can varywithin a single LIT tape 186. In one embodiment, the tapes 174, 176 arejoined together in a face-to-face manner in which the test elements 178generally face the lancet tape 176, and in another embodiment, the testelements 178 face away from the lancet tape 176. In one form, when thetest elements 178 face the lancet tape 176, the width of the lancet tape176 is shorter such that the contacts 47 on the test element tape 174remain exposed for contact with the meter.

FIG. 13 shows a cross-sectional view of a cartridge 188 in which the LITtape 186 is housed. Like the previous embodiments, the cartridge 188includes supply 190 and waste 192 compartments in which respectivelyunused and used sections of the LIT tape 186 are stored. In addition,the cartridge 188 includes a sampling portion 194 where a fluid sampleis collected and analyzed. The sampling portion 194 includes feedmechanism 156 for feeding the LIT tape 186, one or more guides 154 thatguide the LIT tape 186, and the sample opening 74 through which thesample is drawn.

In the supply compartment 190, the test elements 178 and the lancetelements 182 are packed in a stacked configuration. In other words, thetest elements 178 in the test element tape 174 are folded upon oneanother, and the lancet elements 182 in the lancet tape 176 are foldedupon one another. This results in the folded sections of the testelement 174 and the lancet 176 tapes being positioned in a side-by-sidefashion. As the feed mechanism 156 indexes the LIT tape 186, the LITtape 186 unfolds in an accordion fashion. Once the LIT tape reaches thesampling portion 194, opposing guides 154 straighten the LIT tape 186such that test element 174 and lancet 176 tapes are sandwiched together.Consequently, the test 178 and lancet 182 elements are brought togetherto create a LIT unit 196, at least on temporary basis. In theillustrated embodiment, opposing guides 154 squeeze the tapes 174, 176together, but in other embodiments, other mechanisms can be used topress the tapes 174, 176 together. Once indexed over the sample opening74, the lancet unit 182 of the LIT unit 196 can be used to form anincision from which a fluid sample is drawn and analyzed via the testelement 178 of the LIT unit 196.

Afterwards, the now used LIT unit 196 is indexed into the wastecompartment 192. In the waste compartment 192, the test element 174 andlancet element 176 tapes spread apart in an accordion fashion until theLIT tape 186 is folded in a stacked fashion like in the supplycompartment 190. With such a construction, the packing density of theLIT tape 186 is enhanced such that the length of the supply 190 andwaste 192 compartments can be shortened. Moreover, the risk of crosscontamination between the test elements 178 and the lancet elements 182before use is reduced because the test elements 178 and lancet elements182 remain generally apart prior to use and only come into full contactjust before use.

A variation of a test element tape 198 and lancet tape 200 that can beused in the cartridge 188 of FIG. 13, as well as other types ofcartridges, is illustrated in FIGS. 14 and 15. As can be seen, the testelement tape 198 in FIG. 14 has the test elements 178 disposed on everyother section of the sterility sheet 24, such that test elements 178have blank or cover sections 202 in between the fold lines 43. Likewise,the lancet tape 200 in FIG. 15 has cover sections 202 in between thelancet elements 182. In the illustrated embodiment, only a single coversection 202 is located between the test 178 and lancet 182 elements, butin other embodiments, more than one cover section 202 can be located inbetween the elements 178, 182. The intervals of cover sections 202 canvary within the tape and/or vary from tape to tape. Moreover, the testtape 198 and the lancet tape 200 can have different intervals of coversections 202. The cover sections 202 of the sterility sheet 24 fold overthe test 178 and lancet 182 elements so as to protect and maintain thesterility of the elements 178, 182. As the tapes 198, 200 unfold, thecover sections 202 peel off the test 178 and lancet 182 elements,thereby exposing the test 178 and lancet 182 elements for testingpurposes. For the FIG. 13 cartridge 188, the test 198 and lancet 200tapes can be connected at join locations 184 or at other locations. Inother embodiments, such as illustrated in FIG. 16, the test 198 andlancet 200 tapes can be disconnected before, during, and/or aftercollecting the fluid sample.

FIG. 16 illustrates a LIT cartridge 204 according to another embodiment.In the illustrated embodiment, the cartridge 204 has a supplycompartment 206 and a waste compartment 208 in which the test elementtape 174 and the lancet tape 176 are stored separately. With the tapes174, 176 separate, sterilization and calibration can be simplified alongwith the risk of cross contamination can be reduced. In otherembodiments, the tapes 174, 176 can be connected together for storagepurposes before or after use. It should be recognized that the cartridge204 can house a variety of tapes, like the test element tape 198 of FIG.14 and/or the lancet tape 200 of FIG. 15, to name a few examples.Between the supply 206 and waste 208 compartments, the cartridge 204 hasa sampling portion 210 where the fluid sample is acquired and/oranalyzed. In one embodiment, the sampling portion 210 includes one ormore tape guides 154, one or more feed mechanisms 156, and the samplingopening 74 where the fluid is sampled. In the embodiment shown, thesampling portion 210 includes two pairs of guides 154 that position thetapes 174, 176 in close proximity to one another or in contact with oneanother so as to form, at least on a temporary basis, a LIT unit 212 forsampling and analyzing fluid samples. In one form, the tapes 174, 176are pressed against another so that the test element 178 is able tocollect fluid from the incision formed with the lancet element 182. Inother forms, the tapes 174, 176 can be spaced slightly apart, but stillin close proximity so that the test element 178 is still able to collectfluid. It should be understood that the sampling portion 210 can beconfigured differently in other embodiments. For example, the guides 154can be optional in other embodiments and/or other types of feedmechanisms 156 can be used. The waste compartment 208 in the embodimentshown includes a separator member 214 that separates the tapes 174, 176apart, but the separator member 214 can be optional in otherembodiments.

From the previous discussion, it should be appreciated that the LITunits as well as the meters can be used to sample and analyze body fluidfrom various body parts like fingers and alternate sites, such as theforearm, for example. Moreover, the LIT units can be used to analyzenumerous types of body fluids, such as interstitial fluid and blood, toname a few examples. The body fluid samples can be collected from bodyfluid bled onto the surface of the tissue or can be directly drawn frombelow the surface of the tissue. It also should be recognized that thefeatures of the cartridges can be modified for use in other types ofmeters besides the one illustrated in the drawings. Conversely, theabove-described meters can be used in conjunction with other types ofcartridges. The cartridges and/or tapes can include machine readablecoding that can provide a wide variety of information, such as lotcoding and calibration information. For instance, the cartridges caninclude machine readable coding like barcodes, radio frequencyidentification (RFID) tags, magnetic encoding, electronic memory chips,and/or identification resistors, to name a few examples.

It is envisioned that that compartments in the cartridges can beintegrated together to form a single unit or can be separate. Further,the waste and supply compartments in other embodiments can incorporatesprings or other biasing members to bias the tapes. Moreover, the supplycompartments can include desiccants for stabilizing the humidity of thesupply compartments.

Regarding the tapes for the above-discussed embodiments, it iscontemplated that a leader section can be incorporated into the tapes.It also should be appreciated that the tapes can be folded and/ororiented in other manners, besides in the manners as illustrated in thedrawings. Furthermore, the LIT units in further embodiments can beconfigured in manners different from those shown in the drawings. Forexample, the lancet can be immovable or fixed relative to the testelement. In another example, the lancet retracts via a rotationalmovement instead of linearly and/or the lancet extends at an anglerelative to the opening of the capillary channel. It is contemplatedthat selected features from the various embodiments can be combinedtogether in any number of other combinations. For instance, the wastecompartment reel shown in FIG. 2 can be incorporated into the otherillustrated embodiments in order to index the tape. Moreover, selectedfeatures can be adapted for other tapes that are used to collect and/oranalyze body fluid samples, such as lancet tapes or test strip tapes.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected. All publications, patents and patentapplications cited in this specification are herein incorporated byreference as if each individual publication, patent or patentapplication was specifically and individually indicated to beincorporated by reference as set forth in its entirety herein.

1. A method, comprising: creating a lancet integrated tape havinglancets integrated with test elements; forming on the lancet integratedtape a plurality of guide members configured to guide the tape; loadingthe lancet integrated tape into a cartridge in which the guide membersare received into a guide channel of the cartridge; and wherein saidcreating the lancet integrated tape includes joining a tape of thelancets and a tape of the test elements at least at alternating foldlines, and folding the tape of the lancets and the tape of the testelements in an accordion manner in which the lancets and the testelements are folded away from one another.
 2. The method of claim 1,wherein said forming on the lancet integrated tape the plurality ofguide members comprises punching notches in the lancet integrated tapeto define the guide members.
 3. The method of claim 1, wherein saidforming on the lancet integrated tape the plurality of guide memberscomprises locating the guide members on every other section of thefolded lancet integrated tape.
 4. The method of claim 1, wherein theplurality of guide members extend from at least one edge of the lancetintegrated tape.
 5. The method of claim 1, further comprising: whereinsaid creating the lancet integrated tape includes assembling on asterility sheet the test elements, and enclosing in a sterility sheetthe lancets in which each of the lancets is associated with one of thetest elements; sterilizing the lancets; and said assembling on thesterility sheet the plurality of test elements including assembling oneor more components of the test elements that are unaffected by saidsterilization on the sterility sheet prior to said sterilization, andassembling one or more components of the test elements that are affectedby said sterilization on the sterility sheet after said sterilization.6. The method of claim 5, wherein: the test elements are electrochemicalsensors.
 7. The method of claim 5, wherein said enclosing comprises:folding the sterility sheet around the lancets; and sealing thesterility sheet around the lancets.
 8. The method of claim 5, furthercomprising: folding the lancet integrated tape after said enclosing tocreate a folded tape section; and wherein said loading the lancetintegrated tape includes packing the folded tape section into a supplycompartment of the cartridge.
 9. The method of claim 1, furthercomprising: forming tractor holes in the lancet integrated tape.
 10. Themethod of claim 1, wherein said loading the lancet integrated tapeincludes packing the tape of the lancets and the tape of the testelements in the cartridge in a stacked manner.
 11. The method of claim1, further comprising: manufacturing the tape of the test elements to bewider than the tape of the lancets.
 12. The method of claim 1, whereinsaid creating the lancet integrated tape includes: folding a sterilitysheet around the lancets; and sealing the sterility sheet around thelancets.
 13. The method of claim 1, further comprising: sterilizing thelancets separately from the test elements.
 14. A method, comprising:folding a sterility sheet to form two flaps with a fold line in between;sandwiching one or more lancet assemblies between the two flaps of thesterility sheet, wherein each of the lancet assemblies includes a lancetand a guide member with a slot opening through which the lancet extends,wherein said sandwiching includes aligning the slot opening of the guidemember with the fold line of the sterility sheet so that the fold lineof the sterility sheet closes the slot opening of the guide member;sealing the lancet assemblies between the flaps of the sterility sheetto form one or more lancet packets; and attaching one or more testelements to the lancet packets to form one or more lancet integratedtest elements, wherein the test elements each have a capillary channelopening, wherein said attaching includes positioning the test elementsso that the capillary channel opening of each test element is proximalto a corresponding slot opening.
 15. The method of claim 14, comprising:wherein said attaching includes forming one or more electrodes of one ormore electrochemical sensors on the sterility sheet; sterilizing thelancets; and applying reagent to the electrodes after said sterilizing.16. The method of claim 14, further comprising: wherein said attachingincludes creating a lancet integrated tape that includes the lancets andthe test elements; forming on the lancet integrated tape one or moreguide members configured to guide the lancet integrated tape via one ormore guide channels in a cartridge; and loading the lancet integratedtape in the cartridge by inserting the guide members into the guidechannel of the cartridge.
 17. The method of claim 16, wherein saidforming on the lancet integrated tape includes punching notches in thelancet integrated tape to define the guide members.
 18. The method ofclaim 16, further comprising: folding the lancet integrated tape aftersaid enclosing to create a folded tape section; and wherein said loadingthe lancet integrated tape includes packing the folded tape section intoa supply compartment of the cartridge.
 19. The method of claim 16,wherein said forming on the lancet integrated tape the plurality ofguide members comprises locating the guide members on every othersection of the folded lancet integrated tape.
 20. The method of claim16, further comprising: forming tractor holes in the lancet integratedtape.
 21. The method of claim 14, wherein: the test elements areelectrochemical sensors.
 22. The method of claim 14, further comprising:wherein said attaching includes creating a lancet integrated tape thatincludes the lancets and the test elements; and wherein said loading thelancet integrated tape includes packing the tape of the lancets and thetape of the test elements in the cartridge in a stacked manner.
 23. Themethod of claim 14, further comprising: sterilizing the lancetsseparately from the test elements.